International Validation of the QLQ-OH17 for Oral Health (QLQ-OH17)

This study has been completed.

Sponsor:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01724333

First Posted: November 9, 2012

Last Update Posted: April 29, 2016

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Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description.

The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17

The study aims to validate a questionnaire for assessment of oral morbidity, oral health , and quality of life in relation to cancer treatment. Specific outcomes are prevalence of patients with moderate to severe oral morbidity due to cancer treatment (mucositis,stomatitis, taste change, decayed /loose teeth, osteoradionecrosis, ulcers), to investigate if the severity varies with certain background variables , for example, diagnostic group, age, sex, stage of disease, type of treatment, and to investigate the discriminant validity, reliability and responsiveness of the specific items in patient subgroups

Secondary Outcome Measures:

Quality of life [ Time Frame: Up to two years ]

The questionnaire module that is subject to testing of psychometric properties, will be used together with a well-validated quality of life questionnaire, to investigate if oral morbidity affects overall quality of life

The EORTC guidelines will be strictly followed also in phase IV of the module development. Eligible patients will be contacted by the local study coordinator or a study nurse and informed about the study. After having provided written informed consent, they will be presented with the following two questionnaires for self-report of general symptoms, specific dental and oral symptoms, and quality of life issues; the EORTC QLQ-C30 and the QLQ-OH17. In addition to these two, a short debriefing interview will be conducted by study coordinator / study nurse for assessment of feasibility and patients' opinion about the questionnaires.

The case report form (CRF) on medical and demographic data will be completed by the study coordinator / study nurse before or after the patients have completed their part.

A subset of the patients will be assessed twice, as examination of test - retest reliability is important in phase IV of the development process.

Eligibility

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

An international, cross-cultural sample of cancer patients with different diagnoses in different phases of treatment

Phase III and Phase IV reports approved by the EORTC Quality of Life Group Executive Committee. First publication in Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Second publication accepted for publication in Supp Care Cancer, April 2016